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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic ATEC Canister

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  Class 2 Device Recall Hologic ATEC Canister see related information
Date Initiated by Firm May 31, 2016
Date Posted July 19, 2016
Recall Status1 Terminated 3 on May 24, 2017
Recall Number Z-2239-2016
Recall Event ID 74295
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.
Code Information Lot Number: 20150013 and 20150014
Recalling Firm/
Manufacturer		 Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
Manufacturer Reason
for Recall		 Cracks ATEC Canister Lids.
FDA Determined
Cause 2		 Process control
Action Customers were notified of the recall via certified letter beginning on May 31, 2016. The letter requests that customers immediately inventory your supplies of the Recalled product in all appropriate areas and cease use of all affected stock. In addition, they are asked to complete the enclosed Recall Response Card indicating whether you have any of the Recalled product on hand, as well as the quantity of product that you have in stock.
Quantity in Commerce 16,870
Distribution Worldwide distribution. US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, and South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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